Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
NCT ID: NCT00653432
Last Updated: 2023-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
369 participants
INTERVENTIONAL
2008-01-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Monovisc®
Injectable Hyaluronic Acid Gel
Monovisc®
Intra-articular injection
Saline
0.9% Sterile Saline
Saline
0.9% Sterile Saline
Interventions
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Monovisc®
Intra-articular injection
Saline
0.9% Sterile Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 35 to 75 years
* Body Mass Index (BMI) 20 to 40 kg/m2
* Willing and able to provide informed consent
* Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection
* Not pregnant or lactating
* Previous conservative treatment regimen for osteoarthritis (OA)
* Diagnosis of idiopathic OA of the index knee
* OA symptoms for \>= 6 months
* Index knee Kellgren-Lawrence (K-L) grade of II or III
* Index knee Baseline Summed WOMAC Pain Score \>= 200mm and \< 400mm after NSAID washout
* Contralateral Knee K-L grade 0, I or II
* Contralateral Knee Baseline WOMAC Pain Score \< 150mm after NSAID washout
Exclusion Criteria
* Joint disorders which could interfere with study assessments
* Arthroscopy of either knee within 3 months of screening
* Open surgery of index knee within 12 months of screening
* Open surgery of contralateral knee within 3 months of screening
* Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening
* Injection of steroid in index knee within 3 months of screening
* Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection
* Synovial fluid aspirate volume \> 20 milliliters (mL)
* Visual appearance of synovial fluid that contraindicates injection
* Index knee range of motion \< 90 degrees
* Subject participation in other research study within 30 days of screening
* Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study
* Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable
* Other medication or treatments that could interfere with study injection or assessments
* Allergy to gram positive bacterial products or intolerance of acetaminophen
* Active fibromyalgia
* Peripheral neuropathy severe enough to interfere with evaluation of either knee
* Vascular insufficiency severe enough to interfere with evaluation of the subject
* Hemiparesis involving either lower extremity
* Systemic bleeding disorder
* Other conditions which may adversely affect the success of the procedure
35 Years
75 Years
ALL
No
Sponsors
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Anika Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Schmitz, MD
Role: STUDY_DIRECTOR
Prometrika, LLC
Locations
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Clinical Research Consultants
Hoover, Alabama, United States
Novara Clinical Research
Mesa, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Tuscon Orthopaedic Institute
Tucson, Arizona, United States
Providence Clinical Research
Burbank, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Summit Clinical Research
Aurora, Colorado, United States
Boulder Medical Center
Boulder, Colorado, United States
Colorado Orthopedic Consultants
Englewood, Colorado, United States
Plancher Orthopaedic and Sports Medicine
Cos Cob, Connecticut, United States
Community Research Foundation
Miami, Florida, United States
Tampa Medical Clinic
Tampa, Florida, United States
Resurgens Orthopedics
Cumming, Georgia, United States
Intermountain Research Center
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States
Wellborn Clinic
Evansville, Indiana, United States
David Neustadt PSC
Louisville, Kentucky, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Great Lakes Research Group
Bay City, Michigan, United States
Western Montana Clinic
Missoula, Montana, United States
Physician Research Collaboration
Lincoln, Nebraska, United States
Arthritis Center of Reno
Reno, Nevada, United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Brian Gunnlaugson, MD
Johnstown, Pennsylvania, United States
The Arthritis Group
Philadelphia, Pennsylvania, United States
Clinical Research Center of Reading
West Reading, Pennsylvania, United States
SCRI
Germantown, Tennessee, United States
Valley Orthopedic Clinic
Harlingen, Texas, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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Monovisc-0702
Identifier Type: -
Identifier Source: org_study_id
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